Manufacturing controls for sensor calibration using fabrication measurements
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Solution Overview
Problem
Existing continuous glucose monitoring (CGM) sensors face challenges with accuracy due to physiological lag and manufacturing variations, requiring inconvenient fingerstick measurements for calibration, which increase patient burden and complexity.
Innovation Solution
Utilize fabrication process measurement data to develop calibration models for sensing elements, allowing conversion of electrical signals into calibrated measurement parameters without the need for fingerstick measurements by associating fabrication process measurements with calibration factors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fingerstick measurements are used for calibration, then sensor accuracy is improved, but patient burden and complexity increase
Solution Approach 1:
The patent applies preliminary action by performing calibration during the manufacturing process rather than requiring post-deployment fingerstick measurements. Fabrication process measurements (FPMs) are taken during sensor manufacturing to establish calibration factors, which are then stored and applied automatically when the sensor is used. This eliminates the need for patients to perform manual calibration steps.
Solution Approach 2:
The system implements self-service by automatically applying calibration factors derived from fabrication process measurements without requiring user intervention. The calibration is embedded in the sensor's operational parameters, allowing the sensor to self-calibrate based on its manufacturing characteristics rather than requiring manual calibration procedures from the patient.
2Measurement precision
If fingerstick measurements are used for calibration, then sensor accuracy is improved, but device complexity increases
Solution Approach 1:
The patent applies preliminary action by performing calibration during the manufacturing process rather than requiring post-deployment fingerstick measurements. Fabrication process measurements (FPMs) are taken during sensor manufacturing to establish calibration factors, which are then stored and applied automatically when the sensor is used. This eliminates the need for patients to perform manual calibration steps.
Solution Approach 2:
The patent extracts the calibration function from the end-user environment and relocates it to the manufacturing process. By taking out the calibration step from patient usage and performing it during fabrication, the system removes the complexity of manual calibration procedures while maintaining accuracy through automated FPM-based calibration factors.
3Ease of operation
If fabrication process measurement data is used for calibration, then patient burden is reduced, but manufacturing precision requirements increase
Solution Approach 1:
The patent implements feedback by using fabrication process measurements to establish calibration factors that directly compensate for manufacturing variations. The FPMs provide feedback about the actual sensor characteristics during fabrication, allowing calibration factors to be adjusted accordingly. This feedback loop ensures that manufacturing precision requirements are met while enabling automated calibration.
Solution Approach 2:
The patent applies parameter changes by transforming physical fabrication parameters into calibration factors. Measurement parameters from the fabrication process (such as dimensions, material properties, or electrical characteristics) are converted into calibration values that adjust the sensor's output. This parameter transformation allows manufacturing precision to be leveraged for accurate calibration without requiring manual user intervention.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Improves sensor accuracy and reduces patient burden by providing calibrated measurement values for physiological conditions without the need for additional calibration methods, maintaining reliability and user convenience.
Implementation Method 1
obtaining one or more electrical signals from a sensing element of a sensing arrangement, where the one or more electrical signals are influenced by a physiological condition in a body of a patient
Data Source
AI summary
Techniques disclosed herein relate to determining a calibrated measurement value indicative of a physiological condition of a patient using sensor calibration data determined based on fabrication measurements. In some embodiments, the techniques involve obtaining one or more electrical signals from a sensing element of a sensing arrangement, where the one or more electrical signals are influenced by a physiological condition in a body of a patient; obtaining calibration data associated with the sensing element, where the calibration data is based on fabrication process measurement data for the sensing element and a calibration model for a certain physiological condition; and determining, using the one or more electrical signals and the calibration data associated with the sensing element, a calibrated output value indicative of the physiological condition.